Your trusted partner for exceptional sterile fill & finish services
Our state-of-the-art facility is equipped with proven Robotic Gloveless Isolator (RGI) technology, ensuring aseptic filling of vials in a C-graded cleanroom environment. This advanced automation minimizes human intervention, enhancing sterility and precision. Our processes are fully compliant with EU Annex 1 Good Manufacturing Practice (GMP) standards, reflecting our unwavering commitment to quality and regulatory excellence.
Efficiency, compliance and reliability for all production needs
At NorthX Biologics, we understand the importance of efficiency and reliability in the production process. Whether you have small or large-scale production needs, our experienced team is equipped to handle batch sizes ranging from 100 to 1200 vials (2R) per shift, providing flexibility to accommodate diverse project requirements.
Quality control is a top priority at NorthX Biologics. We offer the option for a 100% fill weight check, ensuring precise dosing for each vial. Combined with use of Push-fit closure we have extremely low levels of rejected vials.
Uninterruptible power supply for seamless production
To minimize disruptions in the production process, our facility is equipped with an uninterruptible power supply. This safeguard ensures that your production runs smoothly and efficiently, even in the face of unexpected power outages.
Tailored fill & finish solutions with integrated analytical support
In addition to our standard vial format, we offer a range of customizable options to meet your specific needs. Whether you require different vial sizes, closures, or labeling options, our flexible solutions can accommodate your unique requirements.
In-house drug product analytics for rigorous testing
At NorthX Biologics, we believe in providing comprehensive services to our clients. That’s why we offer in-house drug product analytics. Our team of skilled analytical experts utilizes advanced techniques to conduct rigorous testing, ensuring the quality, safety, and efficacy of your drug product. You can trust us to deliver reliable results and maintain the highest standards of quality assurance.
Choose NorthX Biologics for excellence in aseptic fill finish
Experience the NorthX Biologics difference and let us be your trusted partner in delivering unparalleled quality, reliability, and expertise.
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Robotic gloveless isolator technology enhances regional production of advanced therapeutics
To meet growing demands of advanced therapy manufacturing, production architectures must shift towards agile, efficient manufacturing systems. By integrating robotic gloveless isolator (RGI) technology into bioproduction, manufacturers can meet the…